Mon.Jul 17, 2023

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Sanofi and AZ advance immunization master plan with US nod for infant RSV drug Beyfortus

Fierce Pharma

Sanofi’s immunization scheme is starting to fall into place thanks to an approval that could propel it and its partner AstraZeneca to the front lines of the respiratory syncytial virus (RSV) scene. | Sanofi’s immunization scheme is starting to fall into place thanks to an approval that could propel it and its partner AstraZeneca to the front lines of the RSV scene.

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Condé Nast Health Unveiled Several New Offerings at June Upfront

PM360

During the 2023 Condé Nast Health Upfront , a virtual event that was held on June 27, the media company revealed several new offerings for advertisers that meet the needs of growing industry trends around influencer marketing, video, authentic engagement, and culture as the newest health KPI. In terms of influencer marketing, Condé Nast announced Allure’s Creators Network and the SELF Care Squad, which will allow advertisers to tap into influential voices in health and align with these carefully

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Vyvgart shines in CIDP study, teeing up another potential nod for Argenx's pipeline in a product

Fierce Pharma

From its initial nod in generalized myasthenia gravis (gMG) in 2021 to a subcutaneous approval this summer—and now, a stellar showing in a second neuromuscular disease—Argenx’s flagship drug Vyvgar | From its initial nod in generalized myasthenia gravis (gMG) in 2021 to a subcutaneous approval this summer—and now, a stellar showing in a second neuromuscular disease—Argenx’s flagship drug Vyvgart is proving its merit as a potential pipeline product.

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Amy Turnquist

Pharma Marketing Network

Amy Turnquist has more than 20 years of experience leading teams to create and deliver innovative, client-centric solutions that connect pharmaceutical brands with their HCP and consumer audiences. In her role as a Principal at North Highland, Amy helps healthcare organizations transform their engagement strategy, driving sustainable change and measurable impact by keeping people at the heart of every decision.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Experts flag eye inflammation reports tied to Apellis' geographic atrophy med Syfovre

Fierce Pharma

Apellis Pharmaceuticals' Syfovre, after achieving the first FDA approval for advanced eye disease geographic atrophy, has been associated with rare but severe side effects, according to the America | The American Society of Retinal Specialists sent out a note to doctors on Saturday warning of eye inflammation cases in patients who took Syfovre, including six reports of occlusive retinal vasculitis.

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Ticking the Talons of Healthcare Transparency

MedCity News

As of January 1, employer-sponsored Group Health Plans and Health Insurance Issuers must make make the prices of 500 medical services available via an Internet-based tool. The Transparency in Coverage final rule gets even tougher on January 1, 2024, when the prices of all medical services must be made available via an Internet-based tool.

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Bridging Care Delivery with Clinical Research

PharmExec

In this Q&A, Craig Serra, head of commercial solutions and partnerships within the clinical research business unit at Flatiron Health (affiliate of the Roche Group), shares his perspective on clinical research, the role of data, and Flatiron Health’s efforts to that end.

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In defense of Actemra: Roche sues Biogen over biosimilar infringement claims

Fierce Pharma

Despite a second wind for Actemra courtesy of the COVID-19 pandemic, Roche has warned the interleukin-6 inhibitor’s blockbuster sales run is nearing its end. | Roche and its subsidiaries Genentech and Chugai Pharmaceutical late last week mounted a lawsuit in Massachusetts over claims that Biogen’s proposed biosimilar to Actemra, BIIB800, violates multiple plaintiff-held patents.

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FDA Approval of RSV Drug Gives Infants and Toddlers Long-Lasting Protection

MedCity News

AstraZeneca and Sanofi drug Beyfortus is now FDA approved for preventing respiratory problems from RSV infection in infants and toddlers. Antibody engineering enables the drug to last longer in the body, providing protective effects for potentially the entire RSV season.

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FTC asks Pfizer, Seagen for more information on proposed $43B merger

Fierce Pharma

The FTC has asked Pfizer and Seagen for more information on their proposed $43 billion merger, the Seattle biotech revealed in an SEC filing.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Prominence Health Plan Taps Strive Health for Kidney Care

MedCity News

Prominence Health Medicare Advantage enrollees will have 24/7 access to Strive Health’s specialized care team through a new partnership. Strive Health is also teaming up with Sierra Nevada Specialty Care, a local nephrology clinic in Nevada.

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J&J touts Rybrevant win in newly diagnosed lung cancer, with key Tagrisso head-to-head readout up next

Fierce Pharma

J&J touts Rybrevant win in newly diagnosed lung cancer, with key Tagrisso head-to-head readout up next aliu Mon, 07/17/2023 - 10:21

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First continuous mRNA manufacturing platform to be developed

European Pharmaceutical Review

A new three-year research programme led by researchers at Massachusetts Institute of Technology ( MIT ) is aiming to design the world’s first fully integrated, continuous mRNA manufacturing platform. The resulting pilot-scale system is intended to improve society’s ability to respond to future pandemics as well as accelerate the development and production of mRNA technologies.

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Eli Lilly Strengthens the Case for Going Early in Alzheimer’s Treatment

MedCity News

Alzheimer’s disease patients in the earliest stages of their disease benefited the most from Eli Lilly drug donanemab, which is expected to receive an FDA decision by the end of 2023. Full results from the drug’s pivotal study were presented during the during the Alzheimer’s Association International Conference.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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New data suggests novel mAb could delay progression of early Alzheimer’s

European Pharmaceutical Review

Eli Lilly and Company’s TRAILBLAZER-ALZ 2 study has shown donanemab enabled nearly half of participants at earlier stage of Alzheimer’s to experience no clinical progression at one year, according to full results from the Phase III trial. The data was shared at the 2023 Alzheimer’s Association International Conference (AAIC) and published in the Journal of the American Medical Association (JAMA).

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Fighting AMR with a value and subscription model 

Pharmaceutical Technology

The recent reintroduction of the Pasteur Act seeks to address the global threat that antimicrobial-resistant (AMR) infections pose, one subscription contract at a time.

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NIH spending for drugs approved 2010-2019 lower than industry spending, study finds

European Pharmaceutical Review

New research published in JAMA Health Forum has documented that the US National Institutes of Health (NIH) spent $8.1 billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. This was ~10 percent of reported industry spending. T he article, written researchers at Bentley University, is the first to broadly assess NIH’s contribution to clinical development of new drugs and compare the scale of NIH spending relative to reported spending by ind

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FDA expands Veklury’s use to Covid-19 patients with severe kidney disease

Pharmaceutical Technology

The move follows a positive decision made by the EMA earlier this year, broadening the use of Veklury to the high-risk patient group.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Advice Given by ChatGPT Vs. Human Providers Is Nearly Indistinguishable, NYU Study Says

MedCity News

NYU researchers conducted a study this year in which nearly 400 people were asked to identify whether responses to patient questions were produced by human providers or ChatGPT. Participants had a limited ability to tell the source of the responses apart, so the study authors concluded that the use of LLMs like ChatGPT could be an effective way to streamline healthcare providers’ communication with patients.

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SNIPR celebrates US court’s favourable ruling on CRISPR patent

Pharmaceutical Technology

The US Federal Court overturned a previous ruling in the patent infringement case against Rockefeller University.

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What Misconceptions Does the Healthcare Industry Still Have About Home-Based Care?

MedCity News

The at-home care field holds significant market potential. As the subsector continues to grow, some leaders of home healthcare startups are challenging misconceptions that some other industry stakeholders may still have, including the misbelief that at-home care is only for senior citizens and that this care model lacks scalability.

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A Book Festival That Matters in Kyiv

Copyright Clearance Center

It’s difficult to imagine more challenging circumstances for a book festival than to be held during war.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Cannabinoid company expands into oncology

PharmaTimes

OCTP develops cannabinoid medicines and is looking at potential treatment of cancer malignancies - News - PharmaTimes

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The Kraft Heinz Lawsuit Against Aetna Is the ‘Tip of the Iceberg’

MedCity News

Kraft Heinz recently sued Aetna, claiming that the insurer is not providing all of Kraft Heinz’s medical claims data. More lawsuits of this sort are likely to come, experts warned.

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Ritesh Patel

Pharma Marketing Network

Ritesh bills himself as a digital and social evangelist, and he has been evangelizing digital since the early days of the dot com boom in the late 1990’s. As a young man, he joined Agency.com and quickly began to consult with major fortune 500 companies to evangelize the merits of the World Wide Web. Along the way, he has worked for the likes of Havas, Cushman & Wakefield and began a deep dive into the healthcare arena in 2009 when he joined Inventiv Health as Head of Digital & in

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Vector Laboratories Acquires Quanta BioDesign

PharmaTech

Vector Laboratories announced the acquisition of Quanta BioDesign on July 17, 2023, which further expands the former’s portfolio of bioconjugation linkers and dyes, as well as its manufacturing sector, according to the press release.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Will Reese

Pharma Marketing Network

Will Reese is an experienced Chief Innovation Officer at Cadient, a Cognizant Company, with a demonstrated history of working in the information technology and services industry. He has spent over 15 years at Cadient, holding positions including Senior Marketing Strategist and Chief Innovation Officer. He is professionally skilled in areas like digital strategy, customer relationship management (CRM), experience design, direct marketing, and omni-channel marketing.

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WillowWood Launches Fiberglass Meta® Shock X

Legacy MEDSearch

Building on the success of META® Shock X, WillowWood launches the Fiberglass META® Shock X. The revolutionary META® feet combine responsive energy return with balance, stability, and impact protection. All META® feet feature the industry’s first unibody platform, free of hardware for a minimal and lightweight, but durable design. Fiberglass META Shock® X features our META-Unibody® platform with ultra-low build height just under 5.5″ (138 mm) which allows versatile fitting options for

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Kyle Shannon, Storyvine

Pharma Marketing Network

Kyle Shannon is a seasoned entrepreneur, focused on the intersection of storytelling and brand marketing. With a solid storytelling foundation, he’s got a Fine Arts degree in acting, written seven feature-length screenplays, and founded & managed a professional theatre company in NYC. He’s been involved in entertainment marketing & creative strategy with clients including Oliver Stone and films including “Snakes on a Plane.” & the “Lord of the Rings̶

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TauRx’s deliver Alzheimer’s disease therapy results

PharmaTimes

Company’s hydromethylthionine mesylate therapy reduced neurodegeneration during pivotal trial - News - PharmaTimes

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.